Safety and Efficacy Study of Isolagen TherapyTM in the Treatment of Nasolabial Fold Wrinkles

Castle Creek Biosciences

Status and phase: Completed; Phase 3

Conditions: Bilateral Nasolabial Fold Wrinkles

Treatments: Biological: Autologous Human Fibroblast (azficel-T); Biological: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00649428

IT-R-005

Details and patient eligibility

About

The purpose of this study is to evaluate the safety profile and the treatment effect of Isolagen TherapyTM compared with placebo when administered to bilateral nasolabial fold wrinkles.

Enrollment: 203 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject is at least 18 years of age
• Level of severity of bilateral nasolabial fold wrinkles meeting severity criteria as per protocol
• Level of subject dissatisfaction with both nasolabial fold wrinkles as per protocol
• Ability to comply with the study requirements
• Negative pregnancy test (Females)
• Healthy post-auricular skin for biopsy

Exclusion criteria

• Excessive dermatochalasis of the treatment area
• Inability to lessen the nasolabial fold wrinkles by physically spreading the area apart
• Total area to be treated exceeds 20 cm in length
• Physical attributes which may prevent assessment or treatment as judged by the evaluator
• Use of an investigational product/procedure within 30 days prior to enrollment or plans for use during the study
• Previous treatment with the sponsor's product
• History of active autoimmune disease or organ transplantation
• Diagnosis of cancer, unless successfully treated or in remission (basal cell carcinoma is excluded)
• Active or chronic skin disease
• Known genetic disorders affecting fibroblasts or collagen
• Active systemic infection
• Requires chronic antibiotic or steroidal therapy
• Use of certain commercial products/procedures to the treatment area prior to study enrollment or plans for use during the study
• Use of systemic agents that increase bleeding or clotting, or disorders equated with these effects
• Known allergic reactions to agents used in preparation of treatment
• Excessive exposure to sun without adequate sun protection

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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203 participants in 2 patient groups, including a placebo group

Active

Experimental group

Treatment:

Biological: Autologous Human Fibroblast (azficel-T)

Control

Placebo Comparator group

Treatment:

Biological: Placebo